1. Field of the Invention
The present invention broadly relates to bio-monitoring in patients, and deals more particularly with a system and a method for implementing a protocol for restoring physical functions of the neuromuscular system through bio-feedback.
2. General Background and State of the Art
Many people have movement disabilities caused by disease or injury. Among the causes are cerebrovascular accident or stroke (CVA), traumatic brain injury, multiple sclerosis, spinal cord injury and Parkinson's disease. Stroke is the leading cause of disability in the United States with at least 700,000 new cases each year. Over half of these people have residual physical disability. Current stroke therapy is labor-intensive and costly. Often insurance does not cover the cost of full therapy. One estimate is that the United States spends $30 billion per year to take care of stroke survivors. Seventeen billion dollars of this cost is direct medical expenditures and thirteen billion dollars represent an indirect cost due to lost productivity. Another estimate is that the total direct and indirect costs of stroke are $43.3 billion per year. The number of strokes is projected to increase because of the increase in the over 50 “baby boom” population. Also, new pharmaceutical treatments for stroke are projected to increase the number of patients surviving a stroke and increase the percentage of stroke survivors requiring rehabilitation. Therefore, it is not surprising that a recent estimate indicates the prevalence of stroke will more than double over the next 50 years.
Following a stroke, the initial treatment is to stabilize the patient. This usually occurs in an emergency room and critical care unit. Following stabilization, the patient is typically transferred to a hospital rehab unit. The time in a rehab unit has been significantly reduced in recent years by the pressures of health care reimbursement but could be as much 14 days. Because of the reduced time, very little therapy aimed at restoring function is applied. Patient activities involve learning toileting, transfers between locations and how to perform functions with the unaffected limb which reinforces learned non-use and hinders restoration of function of the affected limb. The level of disability and availability of health care funds determines where the patient goes following discharge from the rehab unit. The most severely afflicted go to a nursing home. Some patients receive comprehensive treatment in Day Treatment facilities, whereas some patients go to out-patient facilities for treatment of specific functional losses, while others receive home health treatment from visiting therapists.
Because of health care reimbursement reductions, therapy time for stroke patients has been significantly decreased. Currently, a majority of time spent in therapy post-stroke concentrates on helping a patient adapt to their disability by teaching toileting skills and transfers. A consequence of this treatment is the emergence of “learned nonuse” that hinders the restoration of available function. Most current rehabilitation therapies are administered on a spaced basis. Recently, concentrated therapies have been developed that improve function in CVA patients by reversing the effects of “learned nonuse”. Animal studies suggest that learned nonuse is established immediately after the initial organic damage. A patient is punished for trying to use the affected limb and is rewarded for using other parts of the body. Over time, healing of the organic damage occurs but the suppression of use learned in the acute phase remains in force. Also, many of the therapies that have been shown to be effective in restoring function involve massed practice. Physical Therapy training techniques have been used by researchers. Significant improvement in limb function was obtained in chronic CVA patients.
Training techniques based on electromyographic (EMG) biofeedback improve motor ability of chronic CVA patients, as demonstrated by some studies. Repetitive concentrated practice produced large therapeutic effects for lower limb function. Researchers have also systematically studied a variation of forced use of hemiplegic extremities which has been labeled Constraint-Induced (CI) Movement Therapy. Some of these experiments compared several massed therapy techniques and all showed very large increases in limb use over the treatment period.
Two very sophisticated robot systems are being developed for treatment and evaluation of CVA patients which have shown some effectiveness in treatment of CVA patients and have developed very useful data for understanding recovery mechanisms; however, the current cost of these systems precludes their widespread clinical use.
Other studies have shown that measured EMG can be used to trigger neuromuscular electrical stimulation in restoring function to CVA patients. However, the discomfort of surface neuromuscular stimulation significantly limits the clinical implementation of this modality for persons with hemiplegia. EMG biofeedback treatment of stroke patients has also shown some success. This treatment uses surface electrodes to capture the electrical activity of a selected muscle group. An electronic unit converts the signals into visual or audio information for the patient. This information is used by the patient to augment or decrease muscle activity.
Accordingly, what is needed is a system and a method that promotes the restoration of physical functions of the neuromuscular system by incorporating into one device, the treatment modalities of repetitive practice, and force and EMG biofeedback. Furthermore, the system should be inexpensive, portable, comfortable, and easy to use either by the patient or by a therapist.